Study to Evaluate Effectiveness of Investigational Device in the Assistance of Detection and Diagnosis of Breast Cancer

Multi-reader, Multi-case, Observer-blind, Retrospective, Pivotal Study to Evaluate Effectiveness of Investigational Device in the Assistance of Detection and Diagnosis of Breast Cancer During Screening Mammography Interpretation

This study aims to evaluate Effectiveness of Investigational Device, Lunit INSIGHT MMG, in the assistance of Detection and Diagnosis of Breast Cancer during Screening Mammography Interpretation.

The Lunit INSIGHT MMG is developed as a computer-assisted detection/diagnosis device based on deep learning technology. In this pivotal study, effectiveness of the investigational device, Lunit INSIGHT MMG, was examined by comparing the reading panelist's interpretation ability between CAD assisted and unassisted during screening mammography interpretation.

Inclusion Criteria:

• Female
• Any ethnic origin
• Acquired with devices from two manufacturers: Hologic and GE
• 4 views (RMLO, LMLO, RCC, LCC) images of FFDM (Full-Field Digital mammography)

Exclusion Criteria:

• Previous core needle biopsy in breast for past 2 years
• Previous vacuum-assisted biopsy, surgical biopsy or surgery in breast
• Previous breast cancer
• Lactating when taking screening mammograms
• Presence of a breast implant in screening mammograms
• Presence of a pacemaker in screening mammograms
• Inadequate quality status such as insufficient anatomical coverage of screening mammograms